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WO2018185917A1 - Tubular body and tubular body having catheter - Google Patents

Tubular body and tubular body having catheter Download PDF

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Publication number
WO2018185917A1
WO2018185917A1 PCT/JP2017/014407 JP2017014407W WO2018185917A1 WO 2018185917 A1 WO2018185917 A1 WO 2018185917A1 JP 2017014407 W JP2017014407 W JP 2017014407W WO 2018185917 A1 WO2018185917 A1 WO 2018185917A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
resin
tubular body
strand
present
Prior art date
Application number
PCT/JP2017/014407
Other languages
French (fr)
Japanese (ja)
Inventor
武史 木塚
Original Assignee
朝日インテック株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 朝日インテック株式会社 filed Critical 朝日インテック株式会社
Priority to JP2019511026A priority Critical patent/JP6734614B2/en
Priority to EP17904780.8A priority patent/EP3607989A4/en
Priority to CN201780062434.6A priority patent/CN109803712B/en
Priority to KR1020197013441A priority patent/KR20190131009A/en
Priority to PCT/JP2017/014407 priority patent/WO2018185917A1/en
Publication of WO2018185917A1 publication Critical patent/WO2018185917A1/en
Priority to US16/424,928 priority patent/US11027094B2/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0097—Catheters; Hollow probes characterised by the hub
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0059—Catheters; Hollow probes characterised by structural features having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/0069—Tip not integral with tube

Definitions

  • the present invention relates to a tubular body and a catheter including the tubular body.
  • a stenosis or occlusion When a stenosis or occlusion is formed in a body lumen such as a blood vessel, a bile duct, or a pancreatic duct, the flow of blood, bile (bile), pancreatic fluid, etc. flowing through the body lumen becomes poor.
  • occlusion part using a catheter has been widely performed.
  • body lumens such as blood vessels, bile ducts, pancreatic ducts, etc.
  • occlusion part is formed in the terminal of a body lumen
  • the guide wire inserted previously curves strongly along a blood body lumen.
  • the catheter used at that time is required to have flexibility to follow a strongly curved guide wire and kink resistance that does not cause kinking even when strongly curved.
  • Patent Document 1 describes a catheter 1 including an inner layer 7, a coil 3 wound around the outer periphery of the inner layer 7, and an outer layer 8 covering the outer periphery of the coil 3 (FIG. See 2).
  • Patent Document 2 discloses an inner layer 13, coils 111 to 114 wound around the outer periphery of the inner layer 13 and arranged in the longitudinal direction, and an outer layer 13 covering the outer periphery of the coils 111 to 114.
  • the catheter 1 provided is described (see FIG. 2 etc.).
  • a coil (hereinafter referred to as “coil body”) is completely fixed between the inner layer and the outer layer over the entire length. Therefore, when the catheter is bent, the wire constituting the coil body cannot move in accordance with the bent shape, and as a result, there is a problem that the flexibility to follow the guide wire is poor.
  • the present invention has been made to solve such a problem, and it is an object of the present invention to provide a catheter that is excellent in flexibility to follow a guide wire and is less likely to cause kinking even when the catheter is strongly curved.
  • a first aspect of the present invention provides a tubular body comprising a hollow resin body and a strand wound in a hollow spiral inside the hollow resin body.
  • the strand is slidable with respect to the resin body.
  • the second aspect of the present invention is a tubular body formed by winding a resin-coated element wire comprising an element wire and a resin body covering the element wire in a hollow spiral shape, and the adjacent resin-coated element.
  • the wire is fixed, and the element wire is slidable with respect to the resin body.
  • the strand forms a gap between the resin body. To do.
  • a fourth aspect of the present invention is the method according to any one of the first aspect of the present invention to the third aspect of the present invention, wherein the wire has a gap at a tip portion of the resin body. It is fixed to the base end part of the resin body.
  • a fifth aspect of the present invention provides the tubular body according to any one of the first aspect to the fourth aspect of the present invention, the distal end tip connected to the distal end of the tubular body, A catheter comprising a connector connected to a proximal end of a tubular body.
  • the strand is a resin Since it can slide with respect to the body, it is possible to prevent kinking of the tubular body and improve the flexibility of the tubular body.
  • the adjacent resin coating Since the strand is fixed and the strand is slidable with respect to the resin body, the kink of the tubular body can be prevented and the flexibility of the tubular body can be further improved.
  • the wire in the first aspect of the invention or the second aspect of the invention, the wire forms a gap between the resin body and the first aspect.
  • the flexibility of the tubular body can be further improved.
  • the strands of the resin body have a gap at the tip of the resin body. Since it is fixed to the base end portion, in addition to the effect of any one of the first to third aspects of the invention, the flexibility of the distal end of the tubular body can be further improved.
  • the tubular body according to any of the first to fourth aspects of the invention Since it is a catheter provided with the connector connected to the end, while preventing a kink, the flexibility which follows a guide wire can be improved.
  • FIG. 1 is an overall view of a catheter (tubular body) according to a first embodiment of the present invention.
  • FIG. 2 is an enlarged cross-sectional view of part A of FIG.
  • FIG. 3 is a view showing a BB cross section of FIG.
  • FIG. 4 is a cross-sectional view showing a portion corresponding to FIG. 2 of the catheter (tubular body) of the second embodiment.
  • FIG. 5 is an overall view of the catheter (tubular body) of the third embodiment.
  • FIG. 6 is an enlarged view of a part of the portion C in FIG.
  • FIG. 7 is an enlarged cross-sectional view of a portion C in FIG.
  • FIG. 8 is a view showing a DD cross section of FIG.
  • FIG. 9 is a cross-sectional view showing a portion corresponding to FIG. 2 of the catheter (tubular body) of the fourth embodiment.
  • FIG. 10 is a cross-sectional view showing a portion corresponding to FIG. 2 of the catheter (tubular body) of
  • FIG. 1 is an overall view of a catheter (tubular body) according to a first embodiment of the present invention
  • FIG. 2 is an enlarged cross-sectional view of a portion A in FIG. 1, and FIG. It is the figure which showed the BB cross section. 1 and 2, the left side in the figure is the front end side (distal side) inserted into the body, and the right side in the figure is the rear end side (proximal side) operated by an operator such as a doctor.
  • a catheter 1 is inserted into a body lumen such as a blood vessel, a bile duct, a pancreatic duct or the like for treatment and diagnosis of a patient, and a catheter shaft 3 (corresponding to the “tubular body” of the present invention); A distal tip 8 connected to the distal end of the catheter shaft 3 and a connector 9 connected to the proximal end of the catheter shaft 3 are provided.
  • the catheter shaft 3 has a hollow cylindrical shape, and as shown in FIG. 2, the inner layer 2, the coil body 7 in which the strands are spirally wound around the outer periphery of the inner layer 2 in the radial direction, and the coil And an outer layer 5 covering the outer periphery of the body 7.
  • the inner layer 2 is a hollow tubular body made of resin, and forms a lumen 4 for inserting a guide wire or other catheter therein.
  • the resin material which comprises the inner layer 2 is not specifically limited, In this embodiment, PTFE (polytetrafluoroethylene) is used.
  • the coil body 7 is formed by spirally winding one strand 7a around the outer periphery of the inner layer 2 so that adjacent strands 7a are separated from each other.
  • stainless steel SUS304
  • the element wire 7a is composed of a single element wire, but is not limited to a single element line, and may be composed of a plurality of element wires. However, flexibility can be further improved by a single strand.
  • the outer layer 5 is made of resin, and covers the outer periphery of the inner layer 2 and the coil body 7 in a tubular shape.
  • the resin material which comprises the outer layer 5 is not specifically limited, In this embodiment, polyamide, polyamide elastomer, polyester, polyurethane, etc. are used.
  • the wire 7a constituting the coil body 7 is slidably disposed with respect to the outer layer 5.
  • the strand 7a is spirally wound around the outer periphery of the inner layer 2, but is not fixed to the inner layer 2 and the outer layer 5, and can be slid in a spiral manner. It is configured.
  • a distal tip 8 made of resin is connected to the distal end of the catheter shaft 3, and the distal tip 8 is a hollow tapered member having a lumen 6 communicating with the lumen 4.
  • tip 8 is not specifically limited, In this embodiment, a polyurethane, a polyurethane elastomer, etc. are used.
  • the tip 8 may contain a radiopaque powder in the resin.
  • a radiopaque powder for example, tungsten powder
  • a technician such as a doctor can position the catheter 1 at the time of imaging. Can be grasped accurately.
  • a connector 9 made of resin is connected to the proximal end of the catheter shaft 3, and the connector 9 is a hollow member having a lumen (not shown) communicating with the lumen 4.
  • the resin material which comprises this connector 9 is not specifically limited, In this embodiment, polycarbonate etc. are used.
  • the catheter shaft 3 or the catheter 1 of this embodiment since the strand 7a which comprises the coil body 7 is arrange
  • FIG. 4 is a cross-sectional view showing a portion corresponding to FIG. 2 of the catheter (tubular body) of the second embodiment.
  • 2nd Embodiment about the member same as the member which comprises the catheter 1 of 1st Embodiment, the same number is attached
  • the left side in the figure is the front end side (distal side) to be inserted into the body, and the right side in the figure is the rear end side (proximal side) operated by an operator such as a doctor.
  • the catheter 10 includes a catheter shaft 13 (corresponding to the “tubular body” of the present invention), a distal tip 8 connected to the distal end of the catheter shaft 13, and a connector 9 connected to the proximal end of the catheter shaft 3.
  • a catheter shaft 13 corresponding to the “tubular body” of the present invention
  • a distal tip 8 connected to the distal end of the catheter shaft 13
  • a connector 9 connected to the proximal end of the catheter shaft 3.
  • the catheter shaft 13 covers the inner layer 2, the coil body 7 in which the wire is spirally wound around the outer periphery of the inner layer 2, and the outer periphery of the coil body 7 in order from the inner side in the radial direction. And an outer layer 15.
  • the outer layer 15 is made of resin, and covers the outer periphery of the inner layer 2 and the coil body 7 in a tubular shape.
  • the resin material which comprises the outer layer 15 is not specifically limited, In this embodiment, polyamide, polyamide elastomer, polyester, polyurethane, etc. are used.
  • the strand 7a which comprises the coil body 7 is arrange
  • the strand 7a is spirally wound around the outer periphery of the inner layer 2, but is not fixed to the inner layer 2 and the outer layer 5, and can be slid in a spiral manner. It is configured.
  • the catheter 10 of the present embodiment Comparing the catheter 10 of the present embodiment with the catheter 1 of the first embodiment, the catheter 10 of the present embodiment has a gap 11 formed between the strand 7a constituting the coil body 7 and the outer layer 15. However, the catheter 1 of the first embodiment is different in that such a gap 11 is not formed.
  • the wire 7a constituting the coil body 7 is slidably arranged with respect to the inner layer 2 and the outer layer 15, and the wire 7a constituting the coil body 7 Since the gap 11 is formed between the outer layer 15 and the outer layer 15, the flexibility of the catheter shaft 13 and the catheter 10 can be further improved.
  • FIG. 5 is an overall view of the catheter (tubular body) of the third embodiment
  • FIG. 6 is an enlarged view of a part of C part of FIG. 5
  • FIG. FIG. 8 is an enlarged cross-sectional view of a portion C
  • FIG. 8 is a view showing a DD cross section of FIG.
  • 3rd Embodiment the same number is attached
  • the left side in the figure is the front end side (distal side) to be inserted into the body, and the right side in the figure is the rear end side (proximal side) operated by an operator such as a doctor.
  • the catheter 20 includes a catheter shaft 23 (corresponding to a “tubular body” of the present invention), a distal tip 8 connected to the distal end of the catheter shaft 23, and a connector 9 connected to the proximal end of the catheter shaft 23.
  • the catheter shaft 23 includes a plurality of resin-coated strands 25 (10 in the present embodiment) each composed of a strand 27 and a resin film 22 covering the outer periphery of the strand 27. ) It is wound in a hollow spiral shape.
  • the resin-coated strands 25 adjacent to each other have each contact portion of the resin film 22 of each resin-coated strand 25 welded in a spiral shape, and the catheter shaft 23 forms a hollow tubular body as a whole. Yes.
  • the catheter shaft 23 forms a lumen 24 having an uneven surface for inserting a guide wire or other catheter therein.
  • the strand 27 of this embodiment is slidable with respect to the resin film 22. Specifically, the strand 27 is spirally wound together with the resin film 22, but is not fixed to the resin film 22, and is configured to be slidable in a spiral. Yes.
  • the resin material which comprises the resin film 22 is not specifically limited, In this embodiment, polyamide, polyamide elastomer, polyester, polyurethane, PTFE (polytetrafluoroethylene), etc. are used.
  • the catheter shaft 23 is configured by a plurality of resin-coated strands 25, but may be configured by a single resin-coated strand 25. However, it is possible to further improve flexibility by configuring with a single resin-coated strand.
  • the catheter shaft 23 is composed of ten resin-coated strands 25, but the number is not limited to ten and may be any number. However, from the viewpoint of flexibility, it is better to configure with a small number of resin-coated strands.
  • a distal tip 8 made of resin is connected to the distal end of the catheter shaft 23.
  • the distal tip 8 is a hollow tapered member having a lumen 6 communicating with the lumen 24.
  • a connector 9 made of resin is connected to the proximal end of the catheter shaft 23.
  • the connector 9 is a hollow member having a lumen (not shown) communicating with the lumen 24.
  • the strand 27 is slidably disposed with respect to the resin film 22, the flexibility of the catheter shaft 23 and the catheter 20 is improved and the catheter shaft is improved. 23 and the kink of the catheter 20 can be prevented.
  • FIG. 9 is a cross-sectional view showing a portion corresponding to FIG. 2 of the catheter (tubular body) of the fourth embodiment.
  • the same members as those constituting the catheter 20 of the third embodiment are denoted by the same reference numerals, and the description thereof is omitted.
  • the left side in the figure is the front end side (distal side) to be inserted into the body, and the right side in the figure is the rear end side (proximal side) operated by an operator such as a doctor.
  • the catheter 30 includes a catheter shaft 33 (corresponding to a “tubular body” of the present invention), a distal tip 8 connected to the distal end of the catheter shaft 33, and a connector 9 connected to the proximal end of the catheter shaft 33.
  • the catheter shaft 33 has a plurality of resin-coated strands 35 (ten in the present embodiment) each consisting of a strand 37 and a resin film 32 that coats the outer periphery of the strand 37. It is wound in a shape.
  • the adjacent resin-coated strands 35 are formed by spirally welding the contact portions of the resin films 32 of the resin-coated strands 35, and the catheter shaft 33 forms a hollow tubular body as a whole. Yes.
  • the catheter shaft 33 forms a lumen 34 having an uneven surface for inserting a guide wire or other catheter therein.
  • the strand 37 of this embodiment is slidable with respect to the resin film 32.
  • the wire 37 is spirally wound together with the resin film 32, but is not fixed to the resin film 32 and is configured to be slidable in a spiral shape. Yes.
  • the resin material which comprises the resin film 32 is not specifically limited, In this embodiment, polyamide, polyamide elastomer, polyester, polyurethane, PTFE (polytetrafluoroethylene), etc. are used.
  • the catheter shaft 33 is configured by a plurality of resin-coated strands 35, but may be configured by a single resin-coated strand 35. However, from the viewpoint of flexibility, it is better to configure with a single resin-coated strand.
  • the catheter shaft 33 was comprised with the ten resin-coated strands 35, it may not be limited to ten and what number may be sufficient. However, from the viewpoint of flexibility, it is better to configure with a small number of resin-coated strands.
  • a distal tip 8 made of resin is connected to the distal end of the catheter shaft 33.
  • the distal tip 8 is a hollow tapered member having a lumen 6 communicating with the lumen 34.
  • a connector 9 made of resin is connected to the proximal end of the catheter shaft 33.
  • the connector 9 is a hollow member having a lumen (not shown) communicating with the lumen 34.
  • the catheter 30 of the present embodiment When comparing the catheter 30 of the present embodiment with the catheter 20 of the third embodiment, the catheter 30 of the present embodiment has a gap 31 formed between the strand 37 and the resin film 32.
  • the catheter 20 of the third embodiment is different in that such a gap is not formed.
  • the wire 37 is slidably disposed with respect to the resin film 32, and the gap portion 31 is formed between the wire 37 and the resin film 32. Therefore, the flexibility of the catheter shaft 33 and the catheter 30 can be further improved.
  • FIG. 10 is a cross-sectional view showing a portion corresponding to FIG. 2 of the catheter (tubular body) of the fifth embodiment.
  • the same members as those constituting the catheter 20 of the third embodiment are denoted by the same reference numerals, and the description thereof is omitted.
  • the left side in the figure is the front end side (distal side) inserted into the body, and the right side in the figure is the rear end side (proximal side) operated by an operator such as a doctor.
  • the catheter 40 includes a catheter shaft 43 (corresponding to the “tubular body” of the present invention), a distal tip 8 connected to the distal end of the catheter shaft 43, and a connector 9 connected to the proximal end of the catheter shaft 43.
  • the catheter shaft 43 has a plurality of resin-coated strands 45 (ten in the present embodiment) each consisting of a strand 47 and a resin film 42 covering the outer periphery of the strand 47. It is wound in a shape.
  • the adjacent resin-coated strands 45 are formed by spirally welding the respective contact portions of the resin film 42 of each resin-coated strand 45, and the catheter shaft 43 forms a hollow tubular body as a whole. Yes.
  • the catheter shaft 43 forms a lumen 44 having an uneven surface for inserting a guide wire or other catheter therein.
  • the strand 47 of this embodiment is slidable with respect to the resin film 42 at portions other than the base end. Specifically, the strand 47 is spirally wound together with the resin film 42, but portions other than the base end of the strand 47 are not fixed to the resin film 42, and the spiral It is configured to be slidable in a shape.
  • a gap portion 41 is formed between the element wire 47 of the present embodiment and the resin film 32. Therefore, the flexibility of the catheter shaft 43 and the catheter 40 can be further improved.
  • the resin material which comprises the resin film 42 is not specifically limited, In this embodiment, polyamide, polyamide elastomer, polyester, polyurethane, PTFE (polytetrafluoroethylene), etc. are used.
  • the catheter shaft 43 is configured by a plurality of resin-coated strands 45, but may be configured by a single resin-coated strand 45. However, from the viewpoint of flexibility, it is better to configure with a single resin-coated strand.
  • the catheter shaft 43 was comprised with the ten resin-coated strands 45, it may not be limited to ten and what number may be sufficient. However, from the viewpoint of flexibility, it is better to configure with a small number of resin-coated strands.
  • a distal tip 8 made of resin is connected to the distal end of the catheter shaft 43.
  • the distal tip 8 is a hollow tapered member having a lumen 6 communicating with the lumen 44.
  • a connector 9 made of resin is connected to the proximal end of the catheter shaft 43.
  • the connector 9 is a hollow member having a lumen (not shown) communicating with the lumen 44.
  • the base wire 47 of the catheter 40 of the present embodiment has its proximal end fixed to the resin film 42, and the distal end portion of the resin film 42 Is formed with a gap portion 49 in which no wire 47 is present, but the catheter 30 of the fourth embodiment is different in that such a gap portion is not formed.
  • the strand 47 is slidably disposed with respect to the resin film 42, and the gap 41 is formed between the strand 47 and the resin film 32.
  • the gap portion 49 where the wire 47 does not exist is formed at the distal end portion of the resin film 42, the flexibility of the catheter shaft 43 and the catheter 40, in particular, the flexibility of the distal end portion can be further improved.

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Abstract

[Problem] To provide a catheter which is configured so as to have excellent flexibility for following a guide wire and such that kinks are not likely to occur when the catheter is bent greatly. [Solution] A catheter shaft 3 including a hollow inner layer 2, a hollow outer layer 5, and a wire 7a wound around in a hollow spiral inside the hollow inner layer 2 and the hollow outer layer 5, wherein the wire 7a is slidable relative to the inner layer 2 and the outer layer 5.

Description

管状体及びその管状体を備えたカテーテルTubular body and catheter provided with the tubular body
本発明は、管状体及びその管状体を備えたカテーテルに関する。 The present invention relates to a tubular body and a catheter including the tubular body.
血管、胆管、膵管等の体内管腔に狭窄部又は閉塞部が形成された場合には、体内管腔を流れる血液、胆汁（胆液）、膵液等の流れが悪くなる。これらの流れを改善する為に、狭窄部又は閉塞部をカテーテルを使用して治療する方法が広く行われてきた。 When a stenosis or occlusion is formed in a body lumen such as a blood vessel, a bile duct, or a pancreatic duct, the flow of blood, bile (bile), pancreatic fluid, etc. flowing through the body lumen becomes poor. In order to improve these flows, the method of treating a stenosis part or an obstruction | occlusion part using a catheter has been widely performed.
一般に、血管、胆管、膵管等の体内管腔は、末端に行くほどその内腔（ルーメン）が細くなり、かつ、湾曲形状が強くなる。そのため、狭窄部又は閉塞部が体内管腔の末端に形成された場合、先行して挿入されるガイドワイヤは、血体内管腔に沿って強く湾曲する。また、その際使用されるカテーテルには、強く湾曲したガイドワイヤに対して追従する柔軟性と、強く湾曲してもキンクを生じない耐キンク性が要求される。 In general, body lumens such as blood vessels, bile ducts, pancreatic ducts, etc., have thinner lumens and stronger curved shapes toward the ends. Therefore, when a stenosis part or an obstruction | occlusion part is formed in the terminal of a body lumen, the guide wire inserted previously curves strongly along a blood body lumen. Further, the catheter used at that time is required to have flexibility to follow a strongly curved guide wire and kink resistance that does not cause kinking even when strongly curved.
従来、例えば、特許文献１には、内層７と、その内層７の外周に巻回されたコイル３と、そのコイル３の外周を被覆する外層８とを備えるカテーテル１が記載されている（図２等参照）。 Conventionally, for example, Patent Document 1 describes a catheter 1 including an inner layer 7, a coil 3 wound around the outer periphery of the inner layer 7, and an outer layer 8 covering the outer periphery of the coil 3 (FIG. See 2).
また、特許文献２には、内層１３と、その内層１３の外周に巻回され、長手方向に複数配置されたコイル１１１～１１４と、それらコイル１１１～１１４コイルの外周を被覆する外層１３とを備えるカテーテル１が記載されている（図２等参照）。 Patent Document 2 discloses an inner layer 13, coils 111 to 114 wound around the outer periphery of the inner layer 13 and arranged in the longitudinal direction, and an outer layer 13 covering the outer periphery of the coils 111 to 114. The catheter 1 provided is described (see FIG. 2 etc.).
しかしながら、特許文献１に記載されたカテーテルにおいては、コイル（以下、「コイル体」と記す）が全長に亘って内層と外層との間に完全に固定されている。そのため、カテーテルが湾曲した際に、コイル体を構成する素線は湾曲形状に応じた動きが出来ず、その結果、ガイドワイヤに対して追従する柔軟性が乏しいという問題があった。 However, in the catheter described in Patent Document 1, a coil (hereinafter referred to as “coil body”) is completely fixed between the inner layer and the outer layer over the entire length. Therefore, when the catheter is bent, the wire constituting the coil body cannot move in accordance with the bent shape, and as a result, there is a problem that the flexibility to follow the guide wire is poor.
また、特許文献２に記載されたカテーテルにおいても、コイル体は複数配置されてはいるものの、それら複数のコイル体は、内層と外層との間に完全に固定されている為、コイル体を構成する素線は、カテーテルが湾曲した際に、その湾曲形状に応じた動きが出来ず、その結果、ガイドワイヤに対して追従する柔軟性が乏しいという問題があった。 Also, in the catheter described in Patent Document 2, although a plurality of coil bodies are arranged, the plurality of coil bodies are completely fixed between the inner layer and the outer layer, so that the coil body is configured. When the catheter is bent, there is a problem that when the catheter is bent, the wire cannot move according to the bent shape, and as a result, the flexibility to follow the guide wire is poor.
特開２００１－２１８８５１号公報JP 2001-218851 A 特開２０１３－１６５９２６号公報JP 2013-165926 A
本発明は、かかる問題を解決する為になされたものであり、ガイドワイヤに対して追従する柔軟性が優れ、かつ、カテーテルが強く湾曲した場合にもキンクを生じ難いカテーテルを提供することを目的とする。 The present invention has been made to solve such a problem, and it is an object of the present invention to provide a catheter that is excellent in flexibility to follow a guide wire and is less likely to cause kinking even when the catheter is strongly curved. And
かかる目的を達成する為に、本発明の第１の態様は、中空状の樹脂体と、その中空状の樹脂体の内部に中空螺旋状に巻回された素線とを備えた管状体において、前記素線は、前記樹脂体に対して摺動可能であることを特徴とする In order to achieve such an object, a first aspect of the present invention provides a tubular body comprising a hollow resin body and a strand wound in a hollow spiral inside the hollow resin body. The strand is slidable with respect to the resin body.
また、本発明の第２の態様は、素線と、その素線を覆う樹脂体とからなる樹脂被覆素線を中空螺旋状に巻回して形成された管状体において、隣接する前記樹脂被覆素線は固着されており、前記素線は、前記樹脂体に対して摺動可能であることを特徴とする。 The second aspect of the present invention is a tubular body formed by winding a resin-coated element wire comprising an element wire and a resin body covering the element wire in a hollow spiral shape, and the adjacent resin-coated element. The wire is fixed, and the element wire is slidable with respect to the resin body.
また、本発明の第３の態様は、本発明の第１の態様または本発明の第２の態様において、前記素線は、前記樹脂体との間に空隙を形成していることを特徴とする。 According to a third aspect of the present invention, in the first aspect of the present invention or the second aspect of the present invention, the strand forms a gap between the resin body. To do.
また、本発明の第４の態様は、本発明の第１の態様乃至本発明の第３の態様の何れかにおいて、前記素線は、前記樹脂体の先端部において空隙を有するように、前記樹脂体の基端部に固着されていることを特徴とする。 Further, a fourth aspect of the present invention is the method according to any one of the first aspect of the present invention to the third aspect of the present invention, wherein the wire has a gap at a tip portion of the resin body. It is fixed to the base end part of the resin body.
さらに、本発明の第５の態様は、本発明の第１の態様乃至本発明の第４の態様の何れかに記載の管状体と、その管状体の先端に接続された先端チップと、前記管状体の基端に接続されたコネクタとを備えたことを特徴とするカテーテルである。 Furthermore, a fifth aspect of the present invention provides the tubular body according to any one of the first aspect to the fourth aspect of the present invention, the distal end tip connected to the distal end of the tubular body, A catheter comprising a connector connected to a proximal end of a tubular body.
本発明の第１の態様によれば、中空状の樹脂体と、その中空状の樹脂体の内部に中空螺旋状に巻回された素線とを備えた管状体において、素線は、樹脂体に対して摺動可能であるので、管状体のキンクを防止するとともに、管状体の柔軟性を向上させることができる。 According to the first aspect of the present invention, in a tubular body including a hollow resin body and a strand wound in a hollow spiral inside the hollow resin body, the strand is a resin Since it can slide with respect to the body, it is possible to prevent kinking of the tubular body and improve the flexibility of the tubular body.
また、本発明の第２の態様によれば、素線と、その素線を覆う樹脂体とからなる樹脂被覆素線を中空螺旋状に巻回して形成された管状体において、隣接する樹脂被覆素線は固着されており、素線は、樹脂体に対して摺動可能であるので、管状体のキンクを防止するとともに、管状体の柔軟性をさらに向上させることができる。 Moreover, according to the second aspect of the present invention, in the tubular body formed by winding a resin-coated element wire composed of an element wire and a resin body covering the element wire into a hollow spiral shape, the adjacent resin coating Since the strand is fixed and the strand is slidable with respect to the resin body, the kink of the tubular body can be prevented and the flexibility of the tubular body can be further improved.
また、本発明の第３の態様によれば、第１の態様の発明または第２の態様の発明において、素線は、樹脂体との間に空隙を形成しているので、第１の態様の発明または第２の態様の発明の効果に加え、管状体の柔軟性をさらに向上させることができる。 According to the third aspect of the present invention, in the first aspect of the invention or the second aspect of the invention, the wire forms a gap between the resin body and the first aspect. In addition to the effect of the invention of the second aspect or the invention of the second aspect, the flexibility of the tubular body can be further improved.
また、本発明の第４の態様によれば、第１の態様の発明乃至第３の態様の発明の何れかにおいて、素線は、樹脂体の先端部において空隙を有するように、樹脂体の基端部に固着されているので、第１の態様の発明乃至第３の態様の発明の何れかの効果に加え、管状体の先端の柔軟性をさらに向上させることができる。 According to the fourth aspect of the present invention, in any one of the first aspect to the third aspect of the invention, the strands of the resin body have a gap at the tip of the resin body. Since it is fixed to the base end portion, in addition to the effect of any one of the first to third aspects of the invention, the flexibility of the distal end of the tubular body can be further improved.
さらに、本発明の第５の態様によれば、第１の態様の発明乃至第４の態様の発明の何れかの管状体と、管状体の先端に接続された先端チップと、管状体の基端に接続されたコネクタとを備えたカテーテルであるので、キンクを防止するとともに、ガイドワイヤに対して追従する柔軟性を向上させることができる。 Furthermore, according to the fifth aspect of the present invention, the tubular body according to any of the first to fourth aspects of the invention, the distal tip connected to the distal end of the tubular body, and the base of the tubular body Since it is a catheter provided with the connector connected to the end, while preventing a kink, the flexibility which follows a guide wire can be improved.
図１は、本発明の第１実施形態のカテーテル（管状体）の全体図を示した図である。FIG. 1 is an overall view of a catheter (tubular body) according to a first embodiment of the present invention. 図２は、図１のＡ部を拡大した断面図である。FIG. 2 is an enlarged cross-sectional view of part A of FIG. 図３は、図１のＢ－Ｂ断面を示した図である。FIG. 3 is a view showing a BB cross section of FIG. 図４は、第２実施形態のカテーテル（管状体）の図２に相当する部分を示した断面図である。FIG. 4 is a cross-sectional view showing a portion corresponding to FIG. 2 of the catheter (tubular body) of the second embodiment. 図５は、第３実施形態のカテーテル（管状体）の全体図を示した図である。FIG. 5 is an overall view of the catheter (tubular body) of the third embodiment. 図６は、図５のC部の一部を拡大した拡大図である。FIG. 6 is an enlarged view of a part of the portion C in FIG. 図７は、図５のC部を拡大した断面図である。FIG. 7 is an enlarged cross-sectional view of a portion C in FIG. 図８は、図５のD－D断面を示した図である。FIG. 8 is a view showing a DD cross section of FIG. 図９は、第４実施形態のカテーテル（管状体）の図２に相当する部分を示した断面図である。FIG. 9 is a cross-sectional view showing a portion corresponding to FIG. 2 of the catheter (tubular body) of the fourth embodiment. 図１０は、第５実施形態のカテーテル（管状体）の図２に相当する部分を示した断面図である。FIG. 10 is a cross-sectional view showing a portion corresponding to FIG. 2 of the catheter (tubular body) of the fifth embodiment.
　以下、図面を参照して、本発明の実施形態について説明する。
＜第１実施形態＞
先ず、本発明の第１実施形態のカテーテルについて、図１～図３を参照して説明する。
図１は、本発明の第１実施形態のカテーテル（管状体）の全体図を示した図であり、図２は、図１のＡ部を拡大した断面図であり、図３は、図１のＢ－Ｂ断面を示した図である。
図１及び図２において、図示左側が体内に挿入される先端側（遠位側）、図示右側が医師等の手技者によって操作される後端側（近位側）である。 Embodiments of the present invention will be described below with reference to the drawings.
<First Embodiment>
First, a catheter according to a first embodiment of the present invention will be described with reference to FIGS.
FIG. 1 is an overall view of a catheter (tubular body) according to a first embodiment of the present invention, FIG. 2 is an enlarged cross-sectional view of a portion A in FIG. 1, and FIG. It is the figure which showed the BB cross section.
1 and 2, the left side in the figure is the front end side (distal side) inserted into the body, and the right side in the figure is the rear end side (proximal side) operated by an operator such as a doctor.
図１において、カテーテル１は、患者の治療及び診断の為に血管、胆管、膵管等の体内管腔に挿入されるものであり、カテーテルシャフト３（本発明の「管状体」に相当）と、カテーテルシャフト３の先端に接続された先端チップ８と、カテーテルシャフト３の基端に接続されたコネクタ９とを備える。 In FIG. 1, a catheter 1 is inserted into a body lumen such as a blood vessel, a bile duct, a pancreatic duct or the like for treatment and diagnosis of a patient, and a catheter shaft 3 (corresponding to the “tubular body” of the present invention); A distal tip 8 connected to the distal end of the catheter shaft 3 and a connector 9 connected to the proximal end of the catheter shaft 3 are provided.
カテーテルシャフト３は、中空円筒形状をなし、図２に示されるように、半径方向に内側から順に、内層２と、内層２の外周に素線を螺旋状に巻回したコイル体７と、コイル体７の外周を被覆する外層５とを有している。　 The catheter shaft 3 has a hollow cylindrical shape, and as shown in FIG. 2, the inner layer 2, the coil body 7 in which the strands are spirally wound around the outer periphery of the inner layer 2 in the radial direction, and the coil And an outer layer 5 covering the outer periphery of the body 7. *
内層２は、樹脂からなる中空管状体であり、内部にガイドワイヤまたは他のカテーテルを挿入するためのルーメン４を形成する。内層２を構成する樹脂材料は、特に限定されるものではないが、本実施形態では、ＰＴＦＥ（ポリテトラフルオロチレン）が使用されている。 The inner layer 2 is a hollow tubular body made of resin, and forms a lumen 4 for inserting a guide wire or other catheter therein. Although the resin material which comprises the inner layer 2 is not specifically limited, In this embodiment, PTFE (polytetrafluoroethylene) is used.
コイル体７は、１本の素線７ａを、隣接する素線７ａが離間するように、内層２の外周に螺旋状に巻回して構成されたものである。本実施形態では、コイル体７を構成する素線７ａの材料として、ステンレス鋼（ＳＵＳ３０４）を使用しているが、これに限定されるものではない。コイル体７を構成する素線７ａの材料は、例えば、タングステンやＮｉ－Ｔｉ合金等の金属材料を使用しても良く、強化プラスチック（ＰＥＥＫ）等の樹脂材料を使用しても良い。 The coil body 7 is formed by spirally winding one strand 7a around the outer periphery of the inner layer 2 so that adjacent strands 7a are separated from each other. In the present embodiment, stainless steel (SUS304) is used as the material of the wire 7a constituting the coil body 7, but is not limited to this. As the material of the wire 7a constituting the coil body 7, for example, a metal material such as tungsten or Ni—Ti alloy may be used, or a resin material such as reinforced plastic (PEEK) may be used.
なお、本実施形態では、素線７ａを単一の素線で構成したが、単一の素線に限らず、複数の素線から構成するようにしても良い。但し、単一の素線で構成した方が柔軟性をより向上させることができる。 In the present embodiment, the element wire 7a is composed of a single element wire, but is not limited to a single element line, and may be composed of a plurality of element wires. However, flexibility can be further improved by a single strand.
外層５は、樹脂からなり、内層２及びコイル体７の外周を管状に被覆している。外層５を構成する樹脂材料は、特に限定されるものではないが、本実施形態では、ポリアミド、ポリアミドエラストマー、ポリエステル、ポリウレタン等が使用されている。 The outer layer 5 is made of resin, and covers the outer periphery of the inner layer 2 and the coil body 7 in a tubular shape. Although the resin material which comprises the outer layer 5 is not specifically limited, In this embodiment, polyamide, polyamide elastomer, polyester, polyurethane, etc. are used.
　本実施形態において、コイル体７を構成する素線７ａは、外層５に対して摺動可能に配置されている。具体的には、素線７ａは、内層２の外周に螺旋状に巻回されているのであるが、内層２及び外層５に対して固定されておらず、螺旋状に摺動可能なように構成されている。 In the present embodiment, the wire 7a constituting the coil body 7 is slidably disposed with respect to the outer layer 5. Specifically, the strand 7a is spirally wound around the outer periphery of the inner layer 2, but is not fixed to the inner layer 2 and the outer layer 5, and can be slid in a spiral manner. It is configured.
また、カテーテルシャフト３の先端には、樹脂からなる先端チップ８が接続されており、先端チップ８は、ルーメン４に連通したルーメン６を有する中空テーパ形状の部材である。この先端チップ８を構成する樹脂材料は、特に限定されないが、本実施形態では、ポリウレタン、ポリウレタンエラストマ等が使用されている。 A distal tip 8 made of resin is connected to the distal end of the catheter shaft 3, and the distal tip 8 is a hollow tapered member having a lumen 6 communicating with the lumen 4. Although the resin material which comprises this front-end | tip chip | tip 8 is not specifically limited, In this embodiment, a polyurethane, a polyurethane elastomer, etc. are used.
また、先端チップ８は、樹脂内に放射線不透過性の粉末を含有させても良い。例えば、先端チップ８の樹脂内に約６５ｗ％～約９０ｗ％の範囲で放射線不透過性の粉末（例えば、タングステン粉末）を含有させれば、医師等の手技者は、造影時にカテーテル１の位置を正確に把握することができる。 The tip 8 may contain a radiopaque powder in the resin. For example, if radiopaque powder (for example, tungsten powder) is contained in the resin of the tip 8 in a range of about 65 w% to about 90 w%, a technician such as a doctor can position the catheter 1 at the time of imaging. Can be grasped accurately.
また、カテーテルシャフト３の基端には、樹脂からなるコネクタ９が接続されており、コネクタ９は、ルーメン４に連通したルーメン（図示せず）を有する中空状の部材である。このコネクタ９を構成する樹脂材料は、特に限定されないが、本実施形態では、ポリカーボネート等が使用されている。 A connector 9 made of resin is connected to the proximal end of the catheter shaft 3, and the connector 9 is a hollow member having a lumen (not shown) communicating with the lumen 4. Although the resin material which comprises this connector 9 is not specifically limited, In this embodiment, polycarbonate etc. are used.
本実施形態のカテーテルシャフト３またはカテーテル１によれば、コイル体７を構成する素線７ａが内層２及び外層５に対して摺動可能に配置されているので、カテーテルシャフト３及びカテーテル１の柔軟性を向上させると共に、カテーテルシャフト３及びカテーテル１のキンクを防止することができる。 According to the catheter shaft 3 or the catheter 1 of this embodiment, since the strand 7a which comprises the coil body 7 is arrange | positioned so that sliding with respect to the inner layer 2 and the outer layer 5 is carried out, flexibility of the catheter shaft 3 and the catheter 1 is possible. In addition, the kink between the catheter shaft 3 and the catheter 1 can be prevented.
＜第２実施形態＞
次に、本発明の第２実施形態のカテーテルについて、図４を参照して説明する。図４は、第２実施形態のカテーテル（管状体）の図２に相当する部分を示した断面図である。
　なお、第２実施形態において、第１実施形態のカテーテル１を構成する部材と同一の部材については、同一番号を付し、説明を省略する。 Second Embodiment
Next, a catheter according to a second embodiment of the present invention will be described with reference to FIG. FIG. 4 is a cross-sectional view showing a portion corresponding to FIG. 2 of the catheter (tubular body) of the second embodiment.
In addition, in 2nd Embodiment, about the member same as the member which comprises the catheter 1 of 1st Embodiment, the same number is attached | subjected and description is abbreviate | omitted.
図４においても、図示左側が体内に挿入される先端側（遠位側）、図示右側が医師等の手技者によって操作される後端側（近位側）である。 Also in FIG. 4, the left side in the figure is the front end side (distal side) to be inserted into the body, and the right side in the figure is the rear end side (proximal side) operated by an operator such as a doctor.
図４において、カテーテル１０は、カテーテルシャフト１３（本発明の「管状体」に相当）と、カテーテルシャフト１３の先端に接続された先端チップ８と、カテーテルシャフト３の基端に接続されたコネクタ９とを備える。 In FIG. 4, the catheter 10 includes a catheter shaft 13 (corresponding to the “tubular body” of the present invention), a distal tip 8 connected to the distal end of the catheter shaft 13, and a connector 9 connected to the proximal end of the catheter shaft 3. With.
カテーテルシャフト１３は、図４に示されるように、半径方向に内側から順に、内層２と、内層２の外周に素線を螺旋状に巻回したコイル体７と、コイル体７の外周を被覆する外層１５とを有している。　 As shown in FIG. 4, the catheter shaft 13 covers the inner layer 2, the coil body 7 in which the wire is spirally wound around the outer periphery of the inner layer 2, and the outer periphery of the coil body 7 in order from the inner side in the radial direction. And an outer layer 15. *
外層１５は、樹脂からなり、内層２及びコイル体７の外周を管状に被覆している。外層１５を構成する樹脂材料は、特に限定されるものではないが、本実施形態では、ポリアミド、ポリアミドエラストマー、ポリエステル、ポリウレタン等が使用されている。 The outer layer 15 is made of resin, and covers the outer periphery of the inner layer 2 and the coil body 7 in a tubular shape. Although the resin material which comprises the outer layer 15 is not specifically limited, In this embodiment, polyamide, polyamide elastomer, polyester, polyurethane, etc. are used.
本実施形態において、コイル体７を構成する素線７ａは、第１実施形態と同様に、外層１５に対して摺動可能に配置されている。具体的には、素線７ａは、内層２の外周に螺旋状に巻回されているのであるが、内層２及び外層５に対して固定されておらず、螺旋状に摺動可能なように構成されている。 In this embodiment, the strand 7a which comprises the coil body 7 is arrange | positioned so that sliding with respect to the outer layer 15 is carried out similarly to 1st Embodiment. Specifically, the strand 7a is spirally wound around the outer periphery of the inner layer 2, but is not fixed to the inner layer 2 and the outer layer 5, and can be slid in a spiral manner. It is configured.
　本実施形態のカテーテル１０と第１実施形態のカテーテル１とを比較すると、本実施形態のカテーテル１０には、コイル体７を構成する素線７ａと外層１５との間に空隙部１１が形成されているが、第１実施形態のカテーテル１には、そのような空隙部１１が形成されていない点で相違する。 Comparing the catheter 10 of the present embodiment with the catheter 1 of the first embodiment, the catheter 10 of the present embodiment has a gap 11 formed between the strand 7a constituting the coil body 7 and the outer layer 15. However, the catheter 1 of the first embodiment is different in that such a gap 11 is not formed.
本実施形態のカテーテルシャフト１３またはカテーテル１０によれば、コイル体７を構成する素線７ａが内層２及び外層１５に対して摺動可能に配置され、かつコイル体７を構成する素線７ａと外層１５との間に空隙部１１が形成されているので、カテーテルシャフト１３及びカテーテル１０の柔軟性をさらに向上させることができる。 According to the catheter shaft 13 or the catheter 10 of the present embodiment, the wire 7a constituting the coil body 7 is slidably arranged with respect to the inner layer 2 and the outer layer 15, and the wire 7a constituting the coil body 7 Since the gap 11 is formed between the outer layer 15 and the outer layer 15, the flexibility of the catheter shaft 13 and the catheter 10 can be further improved.
＜第３実施形態＞
次に、本発明の第３実施形態のカテーテルについて、図５～図８を参照して説明する。図５は、第３実施形態のカテーテル（管状体）の全体図を示した図であり、図６は、図５のC部の一部を拡大した拡大図であり、図７は、図５のC部を拡大した断面図であり、図８は、図５のD－D断面を示した図である。
なお、第３実施形態において、第１実施形態のカテーテル１を構成する部材と同一の部材については、同一番号を付し、説明を省略する。 <Third Embodiment>
Next, a catheter according to a third embodiment of the present invention will be described with reference to FIGS. FIG. 5 is an overall view of the catheter (tubular body) of the third embodiment, FIG. 6 is an enlarged view of a part of C part of FIG. 5, and FIG. FIG. 8 is an enlarged cross-sectional view of a portion C, and FIG. 8 is a view showing a DD cross section of FIG.
In addition, in 3rd Embodiment, the same number is attached | subjected about the member same as the member which comprises the catheter 1 of 1st Embodiment, and description is abbreviate | omitted.
図５～図７においても、図示左側が体内に挿入される先端側（遠位側）、図示右側が医師等の手技者によって操作される後端側（近位側）である。 5 to 7, the left side in the figure is the front end side (distal side) to be inserted into the body, and the right side in the figure is the rear end side (proximal side) operated by an operator such as a doctor.
図５において、カテーテル２０は、カテーテルシャフト２３（本発明の「管状体」に相当）と、カテーテルシャフト２３の先端に接続された先端チップ８と、カテーテルシャフト２３の基端に接続されたコネクタ９とを備える。 In FIG. 5, the catheter 20 includes a catheter shaft 23 (corresponding to a “tubular body” of the present invention), a distal tip 8 connected to the distal end of the catheter shaft 23, and a connector 9 connected to the proximal end of the catheter shaft 23. With.
カテーテルシャフト２３は、図６～図８に示されるように、素線２７と、素線２７の外周を被覆した樹脂膜２２とからなる樹脂被覆素線２５を複数本（本実施形態では１０本）中空螺旋状に巻回したものである。ここで、隣接する樹脂被覆素線２５は、各樹脂被覆素線２５の樹脂膜２２の各当接部が螺旋状に溶着されており、カテーテルシャフト２３は、全体として中空管状体を構成している。また、カテーテルシャフト２３は、内部にガイドワイヤまたは他のカテーテルを挿入するための、表面が凸凹形状のルーメン２４を形成している。 As shown in FIGS. 6 to 8, the catheter shaft 23 includes a plurality of resin-coated strands 25 (10 in the present embodiment) each composed of a strand 27 and a resin film 22 covering the outer periphery of the strand 27. ) It is wound in a hollow spiral shape. Here, the resin-coated strands 25 adjacent to each other have each contact portion of the resin film 22 of each resin-coated strand 25 welded in a spiral shape, and the catheter shaft 23 forms a hollow tubular body as a whole. Yes. Further, the catheter shaft 23 forms a lumen 24 having an uneven surface for inserting a guide wire or other catheter therein.
本実施形態の素線２７は、樹脂膜２２に対して摺動可能となっている。具体的には、素線２７は、樹脂膜２２と共に螺旋状に巻回されているのであるが、樹脂膜２２に対して固定されておらず、螺旋状に摺動可能なように構成されている。 The strand 27 of this embodiment is slidable with respect to the resin film 22. Specifically, the strand 27 is spirally wound together with the resin film 22, but is not fixed to the resin film 22, and is configured to be slidable in a spiral. Yes.
樹脂膜２２を構成する樹脂材料は、特に限定されるものではないが、本実施形態では、ポリアミド、ポリアミドエラストマー、ポリエステル、ポリウレタン、ＰＴＦＥ（ポリテトラフルオロチレン）等が使用されている。 Although the resin material which comprises the resin film 22 is not specifically limited, In this embodiment, polyamide, polyamide elastomer, polyester, polyurethane, PTFE (polytetrafluoroethylene), etc. are used.
なお、本実施形態では、カテーテルシャフト２３を、複数本の樹脂被覆素線２５で構成したが、単一の樹脂被覆素線２５で構成するようにしても良い。但し、単一の樹脂被覆素線で構成した方が、柔軟性をより向上させることができる。 In the present embodiment, the catheter shaft 23 is configured by a plurality of resin-coated strands 25, but may be configured by a single resin-coated strand 25. However, it is possible to further improve flexibility by configuring with a single resin-coated strand.
また、本実施形態では、カテーテルシャフト２３を、１０本の樹脂被覆素線２５で構成したが、１０本に限らず、何本であっても良い。但し、柔軟性の観点からは、少ない本数の樹脂被覆素線で構成した方が良い。 In the present embodiment, the catheter shaft 23 is composed of ten resin-coated strands 25, but the number is not limited to ten and may be any number. However, from the viewpoint of flexibility, it is better to configure with a small number of resin-coated strands.
また、カテーテルシャフト２３の先端には、樹脂からなる先端チップ８が接続されている。先端チップ８は、ルーメン２４に連通したルーメン６を有する中空テーパ形状の部材である。 A distal tip 8 made of resin is connected to the distal end of the catheter shaft 23. The distal tip 8 is a hollow tapered member having a lumen 6 communicating with the lumen 24.
また、カテーテルシャフト２３の基端には、樹脂からなるコネクタ９が接続されている。コネクタ９は、ルーメン２４に連通したルーメン（図示せず）を有する中空状の部材である。 A connector 9 made of resin is connected to the proximal end of the catheter shaft 23. The connector 9 is a hollow member having a lumen (not shown) communicating with the lumen 24.
本実施形態のカテーテルシャフト２３またはカテーテル２０によれば、素線２７が樹脂膜２２に対して摺動可能に配置されているので、カテーテルシャフト２３及びカテーテル２０の柔軟性を向上させると共に、カテーテルシャフト２３及びカテーテル２０のキンクを防止することができる。 According to the catheter shaft 23 or the catheter 20 of the present embodiment, since the strand 27 is slidably disposed with respect to the resin film 22, the flexibility of the catheter shaft 23 and the catheter 20 is improved and the catheter shaft is improved. 23 and the kink of the catheter 20 can be prevented.
＜第４実施形態＞
次に、本発明の第４実施形態のカテーテルについて、図９を参照して説明する。図９は、第４実施形態のカテーテル（管状体）の図２に相当する部分を示した断面図である。
なお、第４実施形態において、第３実施形態のカテーテル２０を構成する部材と同一の部材については、同一番号を付し、説明を省略する。 <Fourth embodiment>
Next, a catheter according to a fourth embodiment of the present invention will be described with reference to FIG. FIG. 9 is a cross-sectional view showing a portion corresponding to FIG. 2 of the catheter (tubular body) of the fourth embodiment.
In the fourth embodiment, the same members as those constituting the catheter 20 of the third embodiment are denoted by the same reference numerals, and the description thereof is omitted.
図９においても、図示左側が体内に挿入される先端側（遠位側）、図示右側が医師等の手技者によって操作される後端側（近位側）である。 Also in FIG. 9, the left side in the figure is the front end side (distal side) to be inserted into the body, and the right side in the figure is the rear end side (proximal side) operated by an operator such as a doctor.
図９において、カテーテル３０は、カテーテルシャフト３３（本発明の「管状体」に相当）と、カテーテルシャフト３３の先端に接続された先端チップ８と、カテーテルシャフト３３の基端に接続されたコネクタ９とを備える。 In FIG. 9, the catheter 30 includes a catheter shaft 33 (corresponding to a “tubular body” of the present invention), a distal tip 8 connected to the distal end of the catheter shaft 33, and a connector 9 connected to the proximal end of the catheter shaft 33. With.
カテーテルシャフト３３は、図９に示されるように、素線３７と、素線３７の外周を被覆した樹脂膜３２とからなる樹脂被覆素線３５を複数本（本実施形態では１０本）中空螺旋状に巻回したものである。ここで、隣接する樹脂被覆素線３５は、各樹脂被覆素線３５の樹脂膜３２の各当接部が螺旋状に溶着されており、カテーテルシャフト３３は、全体として中空管状体を構成している。また、カテーテルシャフト３３は、内部にガイドワイヤまたは他のカテーテルを挿入するための、表面が凸凹形状のルーメン３４を形成する。 As shown in FIG. 9, the catheter shaft 33 has a plurality of resin-coated strands 35 (ten in the present embodiment) each consisting of a strand 37 and a resin film 32 that coats the outer periphery of the strand 37. It is wound in a shape. Here, the adjacent resin-coated strands 35 are formed by spirally welding the contact portions of the resin films 32 of the resin-coated strands 35, and the catheter shaft 33 forms a hollow tubular body as a whole. Yes. Further, the catheter shaft 33 forms a lumen 34 having an uneven surface for inserting a guide wire or other catheter therein.
本実施形態の素線３７は、樹脂膜３２に対して摺動可能となっている。具体的には、素線３７は、樹脂膜３２と共に螺旋状に巻回されているのであるが、樹脂膜３２に対して固定されておらず、螺旋状に摺動可能なように構成されている。 The strand 37 of this embodiment is slidable with respect to the resin film 32. Specifically, the wire 37 is spirally wound together with the resin film 32, but is not fixed to the resin film 32 and is configured to be slidable in a spiral shape. Yes.
樹脂膜３２を構成する樹脂材料は、特に限定されるものではないが、本実施形態では、ポリアミド、ポリアミドエラストマー、ポリエステル、ポリウレタン、ＰＴＦＥ（ポリテトラフルオロチレン）等が使用されている。 Although the resin material which comprises the resin film 32 is not specifically limited, In this embodiment, polyamide, polyamide elastomer, polyester, polyurethane, PTFE (polytetrafluoroethylene), etc. are used.
なお、本実施形態では、カテーテルシャフト３３を、複数本の樹脂被覆素線３５で構成したが、単一の樹脂被覆素線３５で構成するようにしても良い。但し、柔軟性の観点からは、単一の樹脂被覆素線で構成した方が良い。 In the present embodiment, the catheter shaft 33 is configured by a plurality of resin-coated strands 35, but may be configured by a single resin-coated strand 35. However, from the viewpoint of flexibility, it is better to configure with a single resin-coated strand.
また、本実施形態では、カテーテルシャフト３３を、１０本の樹脂被覆素線３５で構成したが、１０本に限らず、何本であっても良い。但し、柔軟性の観点からは、少ない本数の樹脂被覆素線で構成した方が良い。 Moreover, in this embodiment, although the catheter shaft 33 was comprised with the ten resin-coated strands 35, it may not be limited to ten and what number may be sufficient. However, from the viewpoint of flexibility, it is better to configure with a small number of resin-coated strands.
また、カテーテルシャフト３３の先端には、樹脂からなる先端チップ８が接続されている。先端チップ８は、ルーメン３４に連通したルーメン６を有する中空テーパ形状の部材である。 A distal tip 8 made of resin is connected to the distal end of the catheter shaft 33. The distal tip 8 is a hollow tapered member having a lumen 6 communicating with the lumen 34.
また、カテーテルシャフト３３の基端には、樹脂からなるコネクタ９が接続されている。コネクタ９は、ルーメン３４に連通したルーメン（図示せず）を有する中空状の部材である。 A connector 9 made of resin is connected to the proximal end of the catheter shaft 33. The connector 9 is a hollow member having a lumen (not shown) communicating with the lumen 34.
本実施形態のカテーテル３０と第３実施形態のカテーテル２０とを比較すると、本実施形態のカテーテル３０には、素線３７と樹脂膜３２との間に空隙部３１が形成されているが、第３実施形態のカテーテル２０には、そのような空隙部が形成されていない点で相違する。 When comparing the catheter 30 of the present embodiment with the catheter 20 of the third embodiment, the catheter 30 of the present embodiment has a gap 31 formed between the strand 37 and the resin film 32. The catheter 20 of the third embodiment is different in that such a gap is not formed.
したがって、本実施形態のカテーテルシャフト３３またはカテーテル３０によれば、素線３７が樹脂膜３２に対して摺動可能に配置され、かつ素線３７と樹脂膜３２との間に空隙部３１が形成されているので、カテーテルシャフト３３及びカテーテル３０の柔軟性をさらに向上させることができる。 Therefore, according to the catheter shaft 33 or the catheter 30 of the present embodiment, the wire 37 is slidably disposed with respect to the resin film 32, and the gap portion 31 is formed between the wire 37 and the resin film 32. Therefore, the flexibility of the catheter shaft 33 and the catheter 30 can be further improved.
＜第５実施形態＞
最後に、本発明の第５実施形態のカテーテルについて、図１０を参照して説明する。図１０は、第５実施形態のカテーテル（管状体）の図２に相当する部分を示した断面図である。
なお、第５実施形態において、第３実施形態のカテーテル２０を構成する部材と同一の部材については、同一番号を付し、説明を省略する。 <Fifth Embodiment>
Finally, a catheter according to a fifth embodiment of the present invention will be described with reference to FIG. FIG. 10 is a cross-sectional view showing a portion corresponding to FIG. 2 of the catheter (tubular body) of the fifth embodiment.
In the fifth embodiment, the same members as those constituting the catheter 20 of the third embodiment are denoted by the same reference numerals, and the description thereof is omitted.
図１０においても、図示左側が体内に挿入される先端側（遠位側）、図示右側が医師等の手技者によって操作される後端側（近位側）である。 Also in FIG. 10, the left side in the figure is the front end side (distal side) inserted into the body, and the right side in the figure is the rear end side (proximal side) operated by an operator such as a doctor.
図１０において、カテーテル４０は、カテーテルシャフト４３（本発明の「管状体」に相当）と、カテーテルシャフト４３の先端に接続された先端チップ８と、カテーテルシャフト４３の基端に接続されたコネクタ９とを備える。 In FIG. 10, the catheter 40 includes a catheter shaft 43 (corresponding to the “tubular body” of the present invention), a distal tip 8 connected to the distal end of the catheter shaft 43, and a connector 9 connected to the proximal end of the catheter shaft 43. With.
カテーテルシャフト４３は、図１０に示されるように、素線４７と、素線４７の外周を被覆した樹脂膜４２とからなる樹脂被覆素線４５を複数本（本実施形態では１０本）中空螺旋状に巻回したものである。ここで、隣接する樹脂被覆素線４５は、各樹脂被覆素線４５の樹脂膜４２の各当接部が螺旋状に溶着されており、カテーテルシャフト４３は、全体として中空管状体を構成している。また、カテーテルシャフト４３は、内部にガイドワイヤまたは他のカテーテルを挿入するための、表面が凸凹形状のルーメン４４を形成する。 As shown in FIG. 10, the catheter shaft 43 has a plurality of resin-coated strands 45 (ten in the present embodiment) each consisting of a strand 47 and a resin film 42 covering the outer periphery of the strand 47. It is wound in a shape. Here, the adjacent resin-coated strands 45 are formed by spirally welding the respective contact portions of the resin film 42 of each resin-coated strand 45, and the catheter shaft 43 forms a hollow tubular body as a whole. Yes. Further, the catheter shaft 43 forms a lumen 44 having an uneven surface for inserting a guide wire or other catheter therein.
本実施形態の素線４７は、その基端以外の部分において、樹脂膜４２に対して摺動可能となっている。具体的には、素線４７は、樹脂膜４２と共に螺旋状に巻回されているのであるが、素線４７の基端以外の部分は、樹脂膜４２に対して固定されておらず、螺旋状に摺動可能なように構成されている。 The strand 47 of this embodiment is slidable with respect to the resin film 42 at portions other than the base end. Specifically, the strand 47 is spirally wound together with the resin film 42, but portions other than the base end of the strand 47 are not fixed to the resin film 42, and the spiral It is configured to be slidable in a shape.
また、本実施形態の素線４７は、樹脂膜３２との間に空隙部４１が形成されている。したがって、カテーテルシャフト４３及びカテーテル４０の柔軟性をさらに向上させることができる。 In addition, a gap portion 41 is formed between the element wire 47 of the present embodiment and the resin film 32. Therefore, the flexibility of the catheter shaft 43 and the catheter 40 can be further improved.
樹脂膜４２を構成する樹脂材料は、特に限定されるものではないが、本実施形態では、ポリアミド、ポリアミドエラストマー、ポリエステル、ポリウレタン、ＰＴＦＥ（ポリテトラフルオロチレン）等が使用されている。 Although the resin material which comprises the resin film 42 is not specifically limited, In this embodiment, polyamide, polyamide elastomer, polyester, polyurethane, PTFE (polytetrafluoroethylene), etc. are used.
なお、本実施形態では、カテーテルシャフト４３を、複数本の樹脂被覆素線４５で構成したが、単一の樹脂被覆素線４５で構成するようにしても良い。但し、柔軟性の観点からは、単一の樹脂被覆素線で構成した方が良い。 In the present embodiment, the catheter shaft 43 is configured by a plurality of resin-coated strands 45, but may be configured by a single resin-coated strand 45. However, from the viewpoint of flexibility, it is better to configure with a single resin-coated strand.
また、本実施形態では、カテーテルシャフト４３を、１０本の樹脂被覆素線４５で構成したが、１０本に限らず、何本であっても良い。但し、柔軟性の観点からは、少ない本数の樹脂被覆素線で構成した方が良い。 Moreover, in this embodiment, although the catheter shaft 43 was comprised with the ten resin-coated strands 45, it may not be limited to ten and what number may be sufficient. However, from the viewpoint of flexibility, it is better to configure with a small number of resin-coated strands.
また、カテーテルシャフト４３の先端には、樹脂からなる先端チップ８が接続されている。先端チップ８は、ルーメン４４に連通したルーメン６を有する中空テーパ形状の部材である。 A distal tip 8 made of resin is connected to the distal end of the catheter shaft 43. The distal tip 8 is a hollow tapered member having a lumen 6 communicating with the lumen 44.
また、カテーテルシャフト４３の基端には、樹脂からなるコネクタ９が接続されている。コネクタ９は、ルーメン４４に連通したルーメン（図示せず）を有する中空状の部材である。 A connector 9 made of resin is connected to the proximal end of the catheter shaft 43. The connector 9 is a hollow member having a lumen (not shown) communicating with the lumen 44.
本実施形態のカテーテル４０と第４実施形態のカテーテル３０とを比較すると、本実施形態のカテーテル４０の素線４７は、その基端が樹脂膜４２に固着されており、樹脂膜４２の先端部分においては、素線４７が存在しない空隙部４９が形成されているが、第４実施形態のカテーテル３０には、そのような空隙部が形成されていない点で相違する。 Comparing the catheter 40 of the present embodiment with the catheter 30 of the fourth embodiment, the base wire 47 of the catheter 40 of the present embodiment has its proximal end fixed to the resin film 42, and the distal end portion of the resin film 42 Is formed with a gap portion 49 in which no wire 47 is present, but the catheter 30 of the fourth embodiment is different in that such a gap portion is not formed.
したがって、本実施形態のカテーテルシャフト４３またはカテーテル４０によれば、素線４７が樹脂膜４２に対して摺動可能に配置され、素線４７と樹脂膜３２との間に空隙部４１が形成され、かつ樹脂膜４２の先端部分において素線４７が存在しない空隙部４９が形成されているので、カテーテルシャフト４３及びカテーテル４０の柔軟性、特に、先端部分の柔軟性をさらに向上させることができる。 Therefore, according to the catheter shaft 43 or the catheter 40 of the present embodiment, the strand 47 is slidably disposed with respect to the resin film 42, and the gap 41 is formed between the strand 47 and the resin film 32. In addition, since the gap portion 49 where the wire 47 does not exist is formed at the distal end portion of the resin film 42, the flexibility of the catheter shaft 43 and the catheter 40, in particular, the flexibility of the distal end portion can be further improved.
１、１０、２０、３０、４０　　　　　　カテーテル
２　　　　　　　　　　　　　　　　　　内層
３、１３、２３、３３、４３　　　　　　カテーテルシャフト（管状体）
４、６、２４、３４、４４　　　　　　　ルーメン
５、１５　　　　　　　　　　　　　　　外層
７　　　　　　　　　　　　　　　　　　コイル
７ａ、２７、３７　　　　　　　　　　　素線
８　　　　　　　　　　　　　　　　　　先端チップ
９　　　　　　　　　　　　　　　　　　コネクタ
１１、３１、４１、４９　　　　　　　　空隙部
２２、３２、４２　　　　　　　　　　　樹脂膜
２５、３５、４５　　　　　　　　　　　樹脂被覆素線 1, 10, 20, 30, 40 Catheter 2 Inner layer 3, 13, 23, 33, 43 Catheter shaft (tubular body)
4, 6, 24, 34, 44 Lumen 5, 15 Outer layer 7 Coil 7a, 27, 37 Wire 8 Tip 9 Connector 11, 31, 41, 49 Cavity 22, 32, 42 Resin film 25, 35, 45 Resin Coated wire

Claims (5)

  1. 中空状の樹脂体と、その中空状の樹脂体の内部に中空螺旋状に巻回された素線とを備えた管状体において、
    前記素線は、前記樹脂体に対して摺動可能であることを特徴とする管状体。     In a tubular body provided with a hollow resin body and a strand wound in a hollow spiral inside the hollow resin body,
    The said strand is slidable with respect to the said resin body, The tubular body characterized by the above-mentioned.
  2. 素線と、その素線を覆う樹脂体とからなる樹脂被覆素線を中空螺旋状に巻回して形成された管状体において、
    隣接する前記樹脂被覆素線は固着されており、
    前記素線は、前記樹脂体に対して摺動可能であることを特徴とする管状体。     In a tubular body formed by winding a resin-coated strand consisting of a strand and a resin body covering the strand in a hollow spiral shape,
    The adjacent resin-coated strands are fixed,
    The said strand is slidable with respect to the said resin body, The tubular body characterized by the above-mentioned.
  3. 前記素線は、前記樹脂体との間に空隙を形成していることを特徴とする請求項１または請求項２に記載の管状体。 The tubular body according to claim 1 or 2, wherein a gap is formed between the element wire and the resin body.
  4. 前記素線は、前記樹脂体の先端部において空隙を有するように、前記樹脂体の基端部に固着されていることを特徴とする請求項１乃至請求項３の何れかに記載の管状体。 The tubular body according to any one of claims 1 to 3, wherein the element wire is fixed to a proximal end portion of the resin body so as to have a gap at a distal end portion of the resin body. .
  5. 請求項１乃至請求項４の何れかに記載の管状体と、
    その管状体の先端に接続された先端チップと、
    前記管状体の基端に接続されたコネクタとを備えたことを特徴とするカテーテル。     The tubular body according to any one of claims 1 to 4,
    A tip chip connected to the tip of the tubular body;
    And a connector connected to a proximal end of the tubular body.
PCT/JP2017/014407 2017-04-06 2017-04-06 Tubular body and tubular body having catheter WO2018185917A1 (en)

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JP2019511026A JP6734614B2 (en) 2017-04-06 2017-04-06 Tubular body and catheter equipped with the tubular body
EP17904780.8A EP3607989A4 (en) 2017-04-06 2017-04-06 Tubular body and tubular body having catheter
CN201780062434.6A CN109803712B (en) 2017-04-06 2017-04-06 Tubular body and catheter having the same
KR1020197013441A KR20190131009A (en) 2017-04-06 2017-04-06 Catheter with tubular body and tubular body
PCT/JP2017/014407 WO2018185917A1 (en) 2017-04-06 2017-04-06 Tubular body and tubular body having catheter
US16/424,928 US11027094B2 (en) 2017-04-06 2019-05-29 Tubular body and catheter having tubular body

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